FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
13465–13488 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 22, 1988
MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
K882429 · KRG
Tpl-Cordis, Inc.
Cardiovascular · 38d
Cleared Jul 20, 1988
SYNCOR (R) MODEL S-801 ECG ELECTRODE
K882216 · DRX
Lectec Corp.
Cardiovascular · 55d
Cleared Jul 18, 1988
TRIAD-EP
K880936 · DRO
Cardiotronics, Inc.
Cardiovascular · 133d
Cleared Jul 18, 1988
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
K881837 · DXY
Telectronics, Inc.
Cardiovascular · 77d
Cleared Jul 18, 1988
FRANZ CATHETER
K881853 · DRF
Ep Technologies, Inc.
Cardiovascular · 76d
Cleared Jul 18, 1988
SIRECUST 1280/1281 & 960/961 PATIENT MONITORS
K881939 · DPS
Siemens Medical Electronics
Cardiovascular · 70d
Cleared Jul 18, 1988
STETH-SHIELD ACCESSORY TO A STETHOSCOPE
K882324 · LDE
Steth-Shield, Inc.
Cardiovascular · 42d
Cleared Jul 18, 1988
26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP
K882479 · DWS
Medtronic Blood Systems, Inc.
Cardiovascular · 32d
Cleared Jul 14, 1988
BUBBLE TRAP-FILTER CAT. NO B180F37
K873316 · DTM
American Omni Medical, Inc.
Cardiovascular · 330d
Cleared Jul 14, 1988
WS 800R THERMAL ARRAY RECORDER
K881831 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 76d
Cleared Jul 12, 1988
PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 101
K874938 · DSB
Sp Innovations, Inc.
Cardiovascular · 221d
Cleared Jul 12, 1988
HORIZON 2000 ARRHYTHMIA MONITORING OPTION
K881273 · DSI
Mennen Medical, Inc.
Cardiovascular · 109d
Cleared Jul 12, 1988
ESCORT - PORTABLE PATIENT MONITOR
K881986 · DXH
Medical Data Electronics
Cardiovascular · 61d
Cleared Jul 12, 1988
HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
K882045 · LDF
Cordis Leads, Inc.
Cardiovascular · 57d
Cleared Jul 12, 1988
MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR
K882513 · DSI
Cardiac Resucitator Corp.
Cardiovascular · 40d
Cleared Jul 06, 1988
SHILEY FEMORAL CORONARY PERFUSION CATHETER
K881733 · DWF
Shiley, Inc.
Cardiovascular · 75d
Cleared Jul 05, 1988
PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA
K881691 · DWF
Shiley, Inc.
Cardiovascular · 77d
Cleared Jul 05, 1988
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · DWS
Buckman Co., Inc.
Cardiovascular · 75d
Cleared Jul 05, 1988
SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER
K881734 · DWF
Shiley, Inc.
Cardiovascular · 74d
Cleared Jun 30, 1988
#557 DISPOSABLE CARDIOVASCULAR CLAMP
K881448 · DXC
Alpha Industries, Inc.
Cardiovascular · 85d
Cleared Jun 28, 1988
RIGEL MODEL MULTICARE 409
K875160 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 196d
Cleared Jun 22, 1988
ACCUSTAT MODEL 102 NON-INVASIVE BLOOD MONITORING
K881272 · DXN
Accustat, Inc.
Cardiovascular · 90d
Cleared Jun 22, 1988
MINI-TEMP(TM)
K881322 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 86d
Cleared Jun 22, 1988
METATECH METAL MICROCLIP
K881447 · DXC
Metatech Corp.
Cardiovascular · 77d